India to push for local manufacturing of APIs, reduce dependence on China

Fresh Delhi: In a bid to reduce India’s dependence on China for active pharmaceutical ingredients (APIs), the chemicals and fertilizers ministry has joined hands to ministries to draw up a road map for increasing their production in the country.

Bulk drugs or APIs are the active raw materials used in medicines to offer them their therapeutic effect.

A high-level task force has been constituted to examine global methods and set up a plan aimed at boosting domestic production of APIs, an 18 April memorandum issued by the chemicals and fertilizers ministry stated.

Typically the task force, headed by minister of state Mansukh L. Mandaviya, will include secretaries from the departments of pharmaceuticals and commercial policy and promotion, the ministry of into the family welfare, and the ministries of environment, commerce and biotechnology.

The director common of the Council of Scientific and Industrial Research, and the Drug Controller General of India, together with one member from each of the pharma lobby groups and experts from the private industry, will also be area of the group which is anticipated to formulate a road chart to bring back India’s API industry with “implementable recommendations”.

“The specific areas of focus may include r and d, purchase and commercialization, advancement the industry, regulatory framework, potential impact on the industry, investments, contribution to the economy, exports, integration with value chains etc, ” the memorandum said.

At present, over 60% of APIs are sourced from the other nations; for some specific APIs, the dependence is over 80-90%, based on the department of pharmaceuticals.

“India continues to rely on imports of key starting materials, intermediates and APIs from Tiongkok, with the share of dependence increasing as time passes. This specific potentially exposes us to raw material supply interruptions and pricing volatility, ” a study released by the Federation of Native indian Chambers of Commerce and Industry in February said.

Some pharma experts feel that this is a futile exercise as the authorities already has adequate facts on the subject. To attain self-sufficiency to conserve drugs and reduce dependence on The far east, the government had previously set up a panel advancing by the then overseer general of Indian Authorities of Medical Research, V. M. Katoch, in 2013. The committee submitted its report in 2015.

“Even that report is accumulating dust. Government should have looked into the advice and implemented them. This particular committee looks like another futile exercise. The panel includes bureaucrats as opposed to experts from the API industry, ” said Chinu Srinivasan, coordinator, All India Drug Action Network, a party of healthcare-focused NGOs.

M. G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which symbolizes 20 of the country’s biggest drug makers, said the government should never postpone action any further.

“The government has enough information. Apart from the Katoch committee record, there are two more reports. Action is very clear but instead of taking action, they may be busy constituting one committee after another. It’s (a) critical time and the government must assure timely action as opposed to wasting time on constituting committees, ” he said.

However, chemicals and fertilizers minister Ananth Kumar can feel the government has intervened at the right time. “The government has accepted many of the tips of the Katoch committee and proceeded with the plan of action. India will not only catch up in APIs but will start competing with other nations around the world, ” he said.